Medico-economic Comparison Between Treatment with Panretinal Photocoagulation by Laser in 1 Session Versus 4 Sessions in Diabetic Retinopathy

Medico-economic Evaluation of Treatment with Panretinal Photocoagulation in One Session Using Multispot Laser Versus Four Sessions Using Single-spot Laser in Patients with Severe Non-proliferative and Early Proliferative Diabetic Retinopathy

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03242031

Acronym

LIGHT

Enrollment

Registered

2017-08-08

Start date

2017-06-21

Completion date

2022-08-31

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Brief summary

Despite the fact that the efficacy of a single session of multispot laser has been demonstrated in the treatment of patients with diabetic retinopathy as compared with four sessions of single-spot laser, the management of panretinal photocoagulation in the different healthcare establishments in France has remained unchanged notably because there is no specific reimbursement for this new treatment protocol. Although the benefits of reducing the number of sessions and thus the costs associated with the treatment for the patient and the payer seem to be obvious, the medico-economic impact of modifying the treatment strategy thanks to the technological changes must be evaluated to provide deciders with additional information.

Interventions

PROCEDUREmonospot panretinal photocoagulation

panretinal photocoagulation with monospot laser

PROCEDUREmultispot panretinal photocoagulation

panretinal photocoagulation with multispot laser

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Persons who have provided written informed consent * Patients with type 1 or 2 diabetes according to World Health Organisation diagnostic criteria. * Patients with severe non proliferative or early proliferative diabetic retinopathy * Visual acuity of the treated eye \>= 20/32 snellen (≥ 0.63 Monoyer units or ≥ 70 letters Early treatment Diabetic Retinopathy Study) * Visual acuity of the contralateral eye \>= 20/200 snellen (≥ 0.10 Monoyer units or ≥ 35 letters Early treatment Diabetic Retinopathy Study) * Patients with a central macular thickness of 350 μm or less on Spectral Domain - Optical Coherence Tomography * Patients with national health insurance cover * Patients over 18 years old

Exclusion criteria

* Uncontrolled diabetes in the previous 6 months with intensive insulin therapy (glycated haemoglobin \> 11). * Uncontrolled hypertension. * Florid diabetic retinopathy floride. * Macular oedema due to causes other than diabetic retinopathy or in a context of vitreomacular traction. * History of intravitreal treatment with anti-angiogenic agent or corticosteroids within the 12 previous months. * History of treatment with laser in panretinal photocoagulation or focal laser on the treated eye. * History of eye surgery or laser capsulotomy within the previous 6 months * History of renal failure requiring dialysis or kidney transplantation for diabetic nephropathy. * Contra-indication for Tropicamide or Neo-synephrine * History of uncontrolled glaucoma or hypertonia * Patient with aphakia * Adult under guardianship * Pegnant or breast-feeding women

Design outcomes

Primary

Measure	Time frame
cost of treatment	9 months after the start of treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026